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Multi-site Evaluation of an Evidence-based Positive Youth Development Program

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ClinicalTrials.gov Identifier: NCT02519530
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Collaborators:
Florida Department of Health
The Office of Adolescent Health, HHS
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
Investigators are carrying out a study to assess the immediate and long-term effects of a positive youth development program (the Teen Outreach Program) on high school youth in Florida. This study will answer the following questions: What is the impact of the Teen Outreach Program on sexual activity and positive youth development at the end of the program and 10 months after the program?

Condition or disease Intervention/treatment Phase
Unintended Pregnancy Adolescent Problem Behavior Behavioral: Teen Outreach Program Not Applicable

Detailed Description:
Schools were randomly allocated to either the intervention or the control group. At treatment (intervention) schools, youth participated in TOP in addition to their Health, HOPE, Critical Thinking, Career Research, or Leadership class. At control (non-intervention) schools, youth simply participated in their business-as-usual Health, HOPE, Critical Thinking, Career Research, or Leadership class. Two cohorts of students were recruited for this study, the first cohort joined the study in August 2012 and the second cohort joined the study in August 2013. A survey was given to youth at both treatment and control schools. The paper-and-pencil survey took approximately 30 minutes and asked questions about youth school, grades, peers, health behaviors, and behaviors related to teen pregnancy, including what the participant believes and does in regards to sexual health. The survey was completely confidential and participant names were not linked to survey responses. All survey materials were pre-approved by school administration and the school district office. Participants will be asked to complete the a survey at pre-intervention, post-intervention, and 10-months post-intervention (Cohort 1 only)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Multi-site Evaluation of an Evidence-based Positive Youth Development Program: a School-level, Longitudinal, Randomized Controlled Trial
Study Start Date : August 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Intervention
Behavioral: Teen Outreach Program
Behavioral: Teen Outreach Program
The Teen Outreach Program (TOP) is a positive youth development program that uses weekly educational peer group sessions, Community Service Learning (CSL), and positive adult guidance to help youth in grades 6-12 build healthy behaviors, life skills, and a sense of purpose. For this study, TOP was implemented in traditional public high schools in Florida and delivered by local health department staff, who were trained and certified as TOP facilitators. Youth enrolled in these classes received the TOP intervention in addition to, not as a replacement for, all business-as-usual curriculum content.

No Intervention: Comparison
This group did not receive TOP, they received business as usual health curriculum offered through the public school system



Primary Outcome Measures :
  1. Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey [ Time Frame: 10 months post program ]
    What is the impact of TOP relative to business as usual on ever having sexual intercourse 10 months after the end of the program?

  2. Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the second follow-up youth survey [ Time Frame: 10 months post program ]
    What is the impact of TOP relative to business as usual on ever having been pregnant or gotten someone pregnant 10 months after the end of the program?


Secondary Outcome Measures :
  1. Number of participants that report ever having sexual intercourse as measured by the first follow-up youth survey [ Time Frame: Immediately post program ]
    What is the impact of TOP relative to business as usual on ever having sexual intercourse at the end of the program?

  2. Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the first follow-up youth survey [ Time Frame: Immediately post program ]
    What is the impact of TOP relative to business as usual on ever having been pregnant or gotten someone pregnant at the end of the program?



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Ages Eligible for Study:   13 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in a class selected for evaluation
  • Had parental consent
  • Proficient in English
  • Capable of independently taking a paper and pencil survey

Exclusion Criteria:

  • Not enrolled in a class randomly selected for the evaluation
  • They joined a participating class after the completion of the parental consent process
  • Not sufficiently proficient in English
  • Could not independently take a paper and pencil survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519530


Sponsors and Collaborators
University of South Florida
Florida Department of Health
The Office of Adolescent Health, HHS
Investigators
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Principal Investigator: Ellen Daley, Ph.D University of South Florida
Principal Investigator: Eric Buhi, Ph.D San Diego State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02519530    
Other Study ID Numbers: 5 TP1AH000017-04-00
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: July 2015
Keywords provided by University of South Florida:
Positive Youth Development
Teen Outreach
Teen Pregnancy Prevention
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms